Randstad Quality Engineer in Newark, Delaware
Newark, DE Salary:
US$ 36 - US$ 45 per hour Date Posted:
Wednesday, October 5, 2016 Experience:
3 years Job Type:
A leader in innovative products and complete solutions in the healthcare industry is currently seeking a Quality Engineer in the Newark, DE area. This is a 1-year CONTRACT position with the possibility of extension. No per diem is available for this assignment. 1st shift (8am-5pm)
Responsibilities for the Quality Engineer
Evaluate safety complaint escalations and make decisions on MDR (Medical Device Reports) reporting per 21CFR803 and other Vigilance Reports according to applicable international regulations and laws, fully documenting those decisions.
File MDR s when needed and communicate as appropriate to the Authorized Representative or Regional Unit. Provide support in all areas associated with MDR/MDVR/MDPR reporting and trending.
Work with Headquarters Support Center (HSC), the Designated Complaint Handling Unit (DCU) and Medical Affairs to review and assess and close potentially adverse events (pMDR s) including MDR and Field Corrective Action decisions and MDR reporting related to Dimension Vista Chemistry reagents.
In addition, support the Commercial Product Quality department when working on post market Dimension Vista Chemistry reagents related issues from the Escalation Review Council (ERC). Provide Commercial Product Quality support for the above mentioned systems Product Health Teams.
Provide Commercial Product Quality support for external audits (LRQA, FDA, etc.).
Requirements for the Quality Engineer
- Experience with IVD products is recommended. Previous experience in evaluating and writing MDRs - Medical Device Reporting is required. Good writing, communication and organizational skills necessary.
Job Number: 125865